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The Ban on 'Off-Label' Pharmaceutical Promotion: Constitutionally Permissible Prophylaxis Against False or Misleading Commercial Speech?


Kate Greenwood


Seton Hall University - School of Law - Center for Health & Pharmaceutical Law & Policy

July, 13 2011

American Journal of Law and Medicine, Vol. 37, p. 278, 2011

Abstract:     
Critics of the Food & Drug Administration’s ban on off-label promotion often claim that it violates the First Amendment because it suppresses pharmaceutical manufacturers’ truthful speech about their legal - and beneficial - products. Characterizing the ban on off-label promotion in this way has more than rhetorical significance. Bans on truthful, non-misleading speech elicit special skepticism because of the belief that they “usually rest solely on the offensive assumption that the public will respond ‘irrationally’ to the truth.” The legislative history of the provisions of the Food Drug and Cosmetic Act that underlie the ban on off-label promotion, however, reveals that Congress was concerned that physicians were responding rationally to false and misleading promotional claims. In this Article, I explore the doctrinal questions raised by conceiving of the ban on off-label promotion not as a ban on “truthful speech to physicians” but instead as a prophylaxis against false and misleading pharmaceutical promotion. I review the evidence that false and misleading claims were commonplace before the ban’s adoption and persist today, along with the enforcement challenges the FDA confronted at that time and would confront were the ban lifted, and conclude the government likely could develop the factual record necessary to establish that Congress’ rejection of an after-the-fact case-by-case approach to combating false and misleading prescription drug promotion is constitutional.

Number of Pages in PDF File: 21

Keywords: First Amendment, commercial speech, off-label promotion

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Date posted: July 15, 2011  

Suggested Citation

Greenwood, Kate, The Ban on 'Off-Label' Pharmaceutical Promotion: Constitutionally Permissible Prophylaxis Against False or Misleading Commercial Speech? (July, 13 2011). American Journal of Law and Medicine, Vol. 37, p. 278, 2011. Available at SSRN: http://ssrn.com/abstract=1885076

Contact Information

Kate Greenwood (Contact Author)
Seton Hall University - School of Law - Center for Health & Pharmaceutical Law & Policy ( email )
One Newark Center
Newark, NJ 07102-5210
United States
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